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Polypropylene not safe in body?
Came across something interesting on legal websites that I didn’t quite understand. Apparently most of the popular brands of mesh use Marlex HGX-030-01 grade polypropylene. But the manufacturer’s Material Safety Data Sheet suggests this material shouldn’t be used in the human body for the purposes of permanent medical implantation.
“MEDICAL APPLICATION CAUTION: Do not use this Saudi Polymers Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues fluids or tissues. Do not use this Saudi Polymers Company material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Saudi Polymers Company under an agreement which expressly acknowledges the contemplated use. Saudi Polymers Company makes no representation, promise, express warranty or implied warranty concerning the suitability of this material for use in implantation in the human body or in contact with internal body fluids or tissues.”
http://www.saudipolymers.com/DataSheets/Polypropylene_HGX-030SP_MSDS_Europe_English.pdf
Any thoughts? Had this been discussed here before?
Thanks
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6 Replies
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My guess the majority of surgeons will rx putting more mesh in to at the very least strengthen the area. However, my guess is also that if a person has experienced crippling pain and or systematic allergic reactions there is no way they will want mesh put back in a second time.
If the mesh was put in openly there are a few surgeons out there that remove the mesh and specialize in a pure tissue repair.
if the mesh was put in laparoscopically very often the actual hernia defect is filled in with scar tissue if the mesh was in for a good amount of time at least a year or two. if there is a hernia upon mesh removal you can request the surgeon to do a pure tissue repair-they can do this either openly after removing the mesh laparoscopic ornthey can repair it while in their laparoscopic after removing the mesh.
if their is any weakenesss but no true hernia they can fix the defect laparoscopic with a pure tissue repair. -
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quote Momof4:It is possible to be allergic to polypropylene, as well. I was allergy tested and had a definite allergic reaction to samples containing varying amounts of polypropylene, which I had a large piece of covering my lower abdomen. I am hoping, moving forward, that allergy testing is considered before implantation, at the very least, in patients with pre-existing conditions such as chronic urticaria or other known allergies. After seeing my reactions, the Allergist felt very strongly that I should have no foreign body implanted. She also suggested that even if you don’t react to a skin test, that doesn’t mean you won’t react to the material once implanted internally. I think this is a very interesting concept and I know Dr. Towfigh is leading the way in this area. It is unbelievable how many of the systemic reactions I was experiencing have improved since mesh removal (still working on the pain aspect). I hate to think of the damage done to my body by the constant inflammation and allergic reaction. It will take time to heal, but since mesh removal, 5 weeks ago, i am moving in the right direction!! Thanks dr. Towfigh!! I am interested to know if anyone else has known allergic reactions to polypropylene.Very interesting, thank you for this.
So what do people who have mesh removal do to repair the original hernias? Is mesh removed and then non-mesh tissue repairs used to fix all issues?
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It is possible to be allergic to polypropylene, as well. I was allergy tested and had a definite allergic reaction to samples containing varying amounts of polypropylene, which I had a large piece of covering my lower abdomen. I am hoping, moving forward, that allergy testing is considered before implantation, at the very least, in patients with pre-existing conditions such as chronic urticaria or other known allergies. After seeing my reactions, the Allergist felt very strongly that I should have no foreign body implanted. She also suggested that even if you don’t react to a skin test, that doesn’t mean you won’t react to the material once implanted internally. I think this is a very interesting concept and I know Dr. Towfigh is leading the way in this area. It is unbelievable how many of the systemic reactions I was experiencing have improved since mesh removal (still working on the pain aspect). I hate to think of the damage done to my body by the constant inflammation and allergic reaction. It will take time to heal, but since mesh removal, 5 weeks ago, i am moving in the right direction!! Thanks dr. Towfigh!! I am interested to know if anyone else has known allergic reactions to polypropylene.
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quote LeviProcter:Polypropylene (PP) has been used since the 1960s by Usher for hernia repair (Read, R.C.: Milestones in the history of hernia surgery: prosthetic repair. Hernia 8(1), 8–14 (2004)). PP itself is relatively inert and does degrade mildly overtime.Thank you for that reference. I’ll see if I can find that paper now.
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Polypropylene (PP) has been used since the 1960s by Usher for hernia repair (Read, R.C.: Milestones in the history of hernia surgery: prosthetic repair. Hernia 8(1), 8–14 (2004)). PP itself is relatively inert and does degrade mildly overtime.
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Do they just say this to avoid lawsuits because they themselves haven’t tested these products in the body? Seems I also read something about how the material passed the FDA’s approval process (for a particular product that was actually voluntarily recalled a few years later).
I’m assuming we have no idea really about long-term performance (10, 15, 20 years). Then again, haven’t synthetic meshes been used since the 1950’s? I guess maybe polypropylene has only been used for 20 years or so?
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